ObesityPhase 4NCT00229229
Comparison of 4 Diets in the Management of Overweight Patients With Vascular Disease
A Phase 4 study testing Low glycemic load diet, Canada Food Guide Diet and Low glycemic index diet in people with Obesity and Cardiovascular Disease, run by Queen's University at 1 site in Canada.
Trial summary
Type 2 diabetes can be prevented by lifestyle changes in high-risk subjects. However, controversies exist on nutritional management of diabetes. Recent data suggests that glucose and insulin responses are affected by not only the quality, but the quantity of carbohydrate consumed. This is referred to as glycemic load. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Obesity, Cardiovascular Disease, Metabolic Syndrome
- What is being tested?
- Low glycemic load diet, Canada Food Guide Diet and Low glycemic index diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2004to Jan 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women, aged 18 to 80 years
- BMI 25-40 kg/m2
- Documented Cardiovascular Disease as evidenced by one or more of the following:
- Coronary atherosclerosis during coronary angiography
- Documented myocardial infarction
- Carotid atherosclerosis during carotid ultrasonography
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- Carotid atherosclerosis during CT angiography
- Carotid atherosclerosis during MR angiography
- Ischemic brain infarct documented on brain imaging studies
Who cannot join
- Documented Type I or II diabetes mellitus (as defined by the Canadian Diabetes Association 2003 Clinical Practice Guidelines for the Prevention and Management of Diabetes in Canada)
- Previous (<5 years ago) individual or group dietary counseling with a registered dietician
- Pregnant or lactating women
- Presence of clinically important hepatic or renal disease
- Inability to communicate effectively using the English language
- Enrollment in another study concurrently
- Inability to give informed consent
Trial locations and contacts
1 site in 1 country.
Canada1 site
Vascular Disease Prevention and Research Centre
Kingston, Ontario, K7L 5G2
About this study
Official title: Comparison of a Low Glycemic Load Diet With a Canada Food Guide Diet in the Management of Overweight Patients With Cardiovascular Disease
Type 2 diabetes can be prevented by lifestyle changes in high-risk subjects. However, controversies exist on nutritional management of diabetes. Recent data suggests that glucose and insulin responses are affected by not only the quality, but the quantity of carbohydrate consumed. This is referred to as glycemic load.
To date, there have not been any prospective randomized studies which examine the utility of a low glycemic load diet.
The purpose of the proposed study is to compare the effectiveness of a Canada Food Guide Diet with a low glycemic load diet on blood sugar control in overweight type 2 diabetics.
Read the detailed description
The primary objective of the proposed study is to compare the effectiveness of a low glycemic load diet with a Canada Food Guide Diet on weight loss in overweight subjects with cardiovascular disease.
The secondary objective of the proposed study is to compare the effectiveness of a low glycemic load diet with both a low glycemic index diet and a low carbohydrate diet on weight loss in overweight subjects with cardiovascular disease. The purpose of this portion of the study is to try to elucidate the relative contributions of the glycemic index and carbohydrate content to the overall effectiveness of a low glycemic load diet. Furthermore, through detailed analysis of actual dietary consumption, and correlation with subsequent weight loss, we hope to gain greater insight into the role of compliance on the success of the various dietary strategies. Restriction of caloric intake is necessary for weight loss regardless of the dietary strategy employed, however, long-term success depends ultimately on the ability of the patients to comply with the said diet. The success of a low glycemic load diet may lie in its superior effectiveness (greater compliance, less calorie consumption) rather than a greater efficacy per se.
A secondary analysis of the effects of all three diets (low glycemic load, low glycemic index and low carbohydrate) on modifying other metabolic factors will also be performed. In particular, the study will examine the effect of the three diets on lipid and fat metabolism, insulin resistance and inflammation.
- Conditions
- Obesity, Cardiovascular Disease, Metabolic Syndrome
- Being tested
- Low glycemic load diet, Canada Food Guide Diet, Low glycemic index diet, Low carbohydrate diet
- Keywords
- Obesity, Cardiovascular Disease, Metabolic Syndrome, Canada Food Guide, Glycemic Index, Glycemic Load
- Medical subject headings
- Obesity, Cardiovascular Diseases, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low glycemic load dietOther
A/A for 6 months intensive dietary intervention followed by a visit 1 year from enrolment
Canada Food Guide DietOther
A/A for 6 months intensive dietary intervention followed by a visit 1 year from enrolment
Low glycemic index dietOther
A/A for 6 months intensive dietary intervention followed by a visit 1 year from enrolment
Low carbohydrate dietOther
A/A for 6 months intensive dietary intervention followed by a visit 1 year from enrolment
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Low glycemic load diet Receives: Other: Low glycemic load diet |
| 2 | Other | Canada Food Guide Diet Receives: Other: Canada Food Guide Diet |
| 3 | Other | Low glycemic index diet Receives: Other: Low glycemic index diet |
| 4 | Other | Low carbohydrate diet Receives: Other: Low carbohydrate diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the effectiveness of a low glycemic load diet with a Canada Food Guide Diet on weight loss in overweight subjects with cardiovascular disease.
Measured: 1 year
Secondary outcomes (1)
To compare the effectiveness of a low glycemic load diet with both a low glycemic index diet and a low carbohydrate diet on weight loss in overweight subjects with cardiovascular disease.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2005 (estimated)
- Study startSep 2004
- Primary completionJan 2009
- Study completionJan 2009
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Investigators
- Stephen A LaHaye, MD, Principal investigator, Vascular Disease Prevention and Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00229229
- Sponsor's protocol ID
- DMED-793-04
- Status last verified
- Jan 2009
- First submitted
- 9 Sep 2005
- Last updated
- 28 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of a Low Glycemic Load Diet With a Canada Food Guide Diet in the Management of Overweight Patients With Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT00229229
- Acronym / sponsor ID
- DMED-793-04
- Conditions
- Obesity, Cardiovascular Disease, Metabolic Syndrome
- Keywords
- Obesity, Cardiovascular Disease, Metabolic Syndrome, Canada Food Guide, Glycemic Index, Glycemic Load
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funding
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Study start
- Sep 2004
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 29 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Type 2 diabetes can be prevented by lifestyle changes in high-risk subjects. However, controversies exist on nutritional management of diabetes. Recent data suggests that glucose and insulin responses are affected by not only the quality, but the quantity of carbohydrate consumed. This is referred to as glycemic load.
To date, there have not been any prospective randomized studies which examine the utility of a low glycemic load diet.
The purpose of the proposed study is to compare the effectiveness of a Canada Food Guide Diet with a low glycemic load diet on blood sugar control in overweight type 2 diabetics.
Detailed description
The primary objective of the proposed study is to compare the effectiveness of a low glycemic load diet with a Canada Food Guide Diet on weight loss in overweight subjects with cardiovascular disease.
The secondary objective of the proposed study is to compare the effectiveness of a low glycemic load diet with both a low glycemic index diet and a low carbohydrate diet on weight loss in overweight subjects with cardiovascular disease. The purpose of this portion of the study is to try to elucidate the relative contributions of the glycemic index and carbohydrate content to the overall effectiveness of a low glycemic load diet. Furthermore, through detailed analysis of actual dietary consumption, and correlation with subsequent weight loss, we hope to gain greater insight into the role of compliance on the success of the various dietary strategies. Restriction of caloric intake is necessary for weight loss regardless of the dietary strategy employed, however, long-term success depends ultimately on the ability of the patients to comply with the said diet. The success of a low glycemic load diet may lie in its superior effectiveness (greater compliance, less calorie consumption) rather than a greater efficacy per se.
A secondary analysis of the effects of all three diets (low glycemic load, low glycemic index and low carbohydrate) on modifying other metabolic factors will also be performed. In particular, the study will examine the effect of the three diets on lipid and fat metabolism, insulin resistance and inflammation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Other: Low glycemic load dietLow glycemic load diet |
| 2 | Other | Other: Canada Food Guide DietCanada Food Guide Diet |
| 3 | Other | Other: Low glycemic index dietLow glycemic index diet |
| 4 | Other | Other: Low carbohydrate dietLow carbohydrate diet |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Men and women, aged 18 to 80 years
- BMI 25-40 kg/m2
- Documented Cardiovascular Disease as evidenced by one or more of the following:
Key exclusion criteria (7 listed)
- Documented Type I or II diabetes mellitus (as defined by the Canadian Diabetes Association 2003 Clinical Practice Guidelines for the Prevention and Management of Diabetes in Canada)
- Previous (<5 years ago) individual or group dietary counseling with a registered dietician
- Pregnant or lactating women
- Presence of clinically important hepatic or renal disease
- Inability to communicate effectively using the English language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low glycemic load dietA/A for 6 months intensive dietary intervention followed by a visit 1 year from enrolment | Other | 1 |
| Canada Food Guide DietA/A for 6 months intensive dietary intervention followed by a visit 1 year from enrolment | Other | 2 |
| Low glycemic index dietA/A for 6 months intensive dietary intervention followed by a visit 1 year from enrolment | Other | 3 |
| Low carbohydrate dietA/A for 6 months intensive dietary intervention followed by a visit 1 year from enrolment | Other | 4 |
Primary outcome
To compare the effectiveness of a low glycemic load diet with a Canada Food Guide Diet on weight loss in overweight subjects with cardiovascular disease.
Time frame: 1 year
1 secondary outcome
To compare the effectiveness of a low glycemic load diet with both a low glycemic index diet and a low carbohydrate diet on weight loss in overweight subjects with cardiovascular disease.
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Lack of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen A LaHaye, MD principal investigator
Vascular Disease Prevention and Research Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Low glycemic load diet, Canada Food Guide Diet and Low glycemic index diet in people with Obesity and Cardiovascular Disease, run by Queen's University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the effectiveness of a low glycemic load diet with a Canada Food Guide Diet on weight loss in overweight subjects with cardiovascular disease. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2009.